US decides to approve Moderna's COVID-19 vaccine on emergency basis, says FT report
A syringe and a bottle reading 'Vaccine COVID-19' next to the Moderna company logo. File
Gulf Today Report
The US Food and Drug Administration (FDA) decided on Thursday night to approve Moderna Inc's coronavirus vaccine on an emergency basis, the Financial Times (FT) reported, citing people close to the process.
The report comes after the FDA said it informed Moderna that it would rapidly work towards the finalisation and issuance of emergency use authorisation (EUA) for its COVID-19 vaccine candidate, according to commissioner Stephen Hahn.
On Thursday, a panel of outside advisers to the FDA overwhelmingly endorsed the emergency use of Moderna's coronavirus vaccine, virtually assuring a second option for protecting against COVID-19 for a pandemic ravaged nation.
The committee voted 20-0 with one abstention that the benefits of the vaccine outweighed its risks in people aged 18 and older.
Epidemiologist Arnold Monto, who chaired the live-streamed discussion, said nothing should be read into the fact that the vote was even more overwhelming than last week's in favor of the Pfizer-BioNTech vaccine.
"Academics have a way of getting involved in details, and what we have done for the last eight or nine hours was to go over the details," he said.
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The meeting came as the number of deaths from the coronavirus quickly approaches 310,000 in the worst-hit country in the world, which this week began vaccinating health care workers and long-term care residents with the Pfizer vaccine.
A week ago, the same panel backed a vaccine from Pfizer Inc and German partner BioNTech SE, leading to an FDA emergency use authorisation (EUA) a day later.
COVID-19 surge pushes US hospitals to brink
Meanwhile, an unrelenting coronavirus surge has pushed besieged hospitals further to the brink as the United States pressed on with its immunisation rollout on Thursday.
COVID-19 hospitalisations rose to record heights for a 19th straight day, with nearly 113,000 coronavirus patients counted in US medical facilities nationwide on Wednesday, while 3,580 more perished, the most yet in a single day.
The virus has claimed almost 308,000 lives in the United States to date, and health experts have warned of a deepening crisis this winter as intensive care units (ICUs) filled up and hospital beds overflowed into hallways.
The US, which has recorded more than 17 million cases of the virus, will probably become the first country to approve the Moderna vaccine.
The small Massachusetts-based biotech firm teamed up with scientists from the US National Institutes of Health on the product and has received more than $2.5 billion from the US government for its efforts.
Health and Human Services Secretary Alex Azar told CNBC on Thursday that 5.9 million doses of the Moderna vaccine have been allotted for states and large cities and were ready to ship nationwide.
The vaccines are not a panacea, however, as they will take months to roll out to a nation where the virus is running rampant and public health measures such as social distancing and mask wearing are being rejected by large parts of the population.
"To go from having a (genetic) sequence of a virus in January to having two vaccines available in December is a remarkable achievement," said Dr James Hildreth, chief executive of Meharry Medical College, who voted to recommend the vaccine for emergency use.
The one abstention came from Dr Michael Kurilla, who works at the National Institutes of Health and felt blanket authorisation for those 18 and older was too broad.
"I'm not convinced that for all of those age groups the benefits do actually outweigh the risk. And I would prefer to see it more targeted towards people at high risk of serious and life threatening COVID disease," he said.
Moderna's vaccine does not require specialised ultra-cold freezers or vast quantities of dry ice, unlike Pfizer's vaccine which needs to be shipped and stored at -70˚C, making it easier to supply rural and remote areas.
